Label: DERMATIZE- benzethonium chloride liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated May 6, 2020

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  • Active ingredient

    Benzethonium chloride, 0.2% w/v

  • Purpose

    Antiseptic

  • Use

    For handwashing to decrease bacteria on skin.

  • Warning

    For external use only.

  • When using this product

    • discontinue use if irritatio and redness develop.
    • do not use in or near eyes.
  • Stop use and ask a doctor if

    Stop use and ask a doctor if irritation or redness develops, or if conditions persist for more than 72 hours.

  • Keep out of reach of children.

    Keep out of reach of children, except under adult supervision.

    • In case of accidental ingestion, see medical attention or contact a poision control cernter immediately.
  • Directions

    • Hands need not be washed prior to using.
    • For one step hand wash/antiseptic skin cleaning.
    • Place 5 milliliters in palm of hand, add water, work up a lather and scrub for 30 seconds.
    • Rinse hands thoroughly with potable water after washing.
  • Inactive ingredients

    Citric acid; 1,3-Dihydroxymethyl-5,5-dimethylhydantoin and 3-iodo-2-propynyl butyl carbamate; Ethoxylated C11 Alcohol; Hydrogenated starch hydrolysate; Hydroxypropyl methylcellulose; N-alkykl (C12-C16)-N, N-dimethylamine oxide; Sodium hydroxide; Water.

  • Questions or comments?

    320-693-2477

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    Product Label

  • INGREDIENTS AND APPEARANCE
    DERMATIZE 
    benzethonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63131-0004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    HYDROXYMETHYL CELLULOSE (UNII: 273FM27VK1)  
    COCAMINE OXIDE (UNII: QWA2IZI6FI)  
    HYDROGENATED STARCH HYDROLYSATE (UNII: 27F77DSJ5V)  
    UNDECETH-7 (UNII: R6B5PCO2JN)  
    WATER (UNII: 059QF0KO0R)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63131-0004-115140 in 1 CASE10/02/2020
    13785 mL in 1 JUG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/02/2020
    Labeler - Anderson Chemical Company (006179220)
    Establishment
    NameAddressID/FEIBusiness Operations
    Anderson Chemical Company006179220manufacture(63131-0004)
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